BCI-838 showed a favorable safety profile, with no treatment-related trends in clinical laboratory results, vital sign measurements, 12 lead ECG results or physical examination findings, and the drug was well tolerated up to the dose levels predicted for efficacy

NeuroVive Pharmaceutical AB, of Lund, Sweden, said Phase I data published in Clinical Drug Investigation showed that its CicloMulsion, a Cremophor-free intravenous cyclosporine formula, was bioequivalent to Sandimmune injection and was safe and well tolerated...CicloMulsion is a cyclophilin inhibitor in clinical development to treat cardiac reperfusion injury and, under the name NeuroSTAT, in development for traumatic brain injury

The Series D enables Zafgen to move clinical and regulatory activities forward without the distraction of additional fundraising, Hurwitz added...Proceeds will support a Phase III trial of Multikine (leukocyte interleukin, injection).

Because of the nature of the registry and vision testing variability, the company said, a clear comparison could not be drawn between registry data and clinical trial results

Net proceeds are expected to total about $44.7 million – or $51.5 million if underwriters exercise in full their overallotment option for 900,000 additional shares – and will be used for commercial launch activities and continued clinical development of the firm's pipeline of extended-release drugs

FDA Seeks Comments on Cellular, Gene Therapy The FDA made available a draft document relating to preclinical assessment of cellular and gene therapy products providing guidance on the substance and scope of information needed to support clinical trials...The brief was filed in connection with an antitrust action against Warner Chilcott, alleging that Warner Chilcott maintained a monopoly for its antibacterial drug Doryx by reformulating the drug three times.

Top-line data from the PEARL-SC trial, presented in June, showed the drug missed its primary endpoint, defined as clinical improvement at 24 weeks in the SLE responder index, but further data showed that the BAFF inhibitor produced sustained and greater treatment effects vs

AiCuris GmbH, of Wuppertal, Germany, said it started the second clinical efficacy trial testing pritelivir (AIC316), its herpes simplex virus (HSV) drug, after data from the first study showed a high degree of efficacy against genital herpes...A Phase Ib study of ProHema achieved its primary objective of demonstrating safety and tolerability and established early clinical proof of concept, including trends of accelerated neutrophil recovery, improved 100-day survival and low rates of graft-vs.-host

Accera Inc., of Broomfield, Colo., started a clinical efficacy trial examining the effects of AC-1204 in patients with mild-to-moderate Alzheimer's disease (AD

Subcutaneous administration achieved efficient conversion to decitabine, resulting in an improved pharmacokinetic profile over the intravenous Dacogen (decitabine) formulation, and clinical responses were observed in the heavily pretreated population of patients with relapsed/refractory intermediate- or high-risk myelodysplastic syndromes or acute myelogenous leukemia

Using Electronic Data in Clinical Trials The FDA also is requesting comments on a revised draft guidance on the use of electronic source data in clinical trials...The document is designed to help sponsors, contract research organizations, data management centers, clinical investigators and others involved in capturing, reviewing and archiving electronic source data in FDA-regulated clinical trials to ensure the reliability, quality, integrity and traceability of the data

The Patient-Centered Outcomes Research Institute (PCORI) will award $12 million in funding through 14 contracts for studies addressing knowledge gaps in comparative clinical effectiveness research

CytoDyn Inc., of Portland, Ore., said it entered a clinical trial agreement with the Division of Infectious Diseases and HIV Medicine at Drexel University College of Medicine to conduct additional Phase II studies of PRO 140, a humanized monoclonal antibody targeting the CCR5 receptor for treating HIV infection...Pozen said it has now completed all the clinical trials intended for inclusion in a new drug application package, targeted for submission no later than the end of April 2013

Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban

The data, compared to month three, showed a further improvement in clinical symptoms linked to RA for patients in whom the Kinoid induced antibody (Abs) to TNF, compared to those without such antibody

The primary endpoint of the study is clinical benefit of AEZS-108...The study, conducted in 20 Asian patients at seven clinical trial sites, compared the outcome of a single intravenous dose of Zybrestat (15, 25, 35 or 45 mg/kg) with placebo...Based on outcomes for safety and tolerability, and measures of absorption, distribution, metabolism and excretion, Path will proceed to the next Phase of clinical trials in 2013

The data were presented during a late-breaking clinical trials session at the 9th International Congress of the Society for Melanoma Research in Hollywood, Calif

The Phase III study met its primary endpoint and demonstrated statistically significant protection against clinical and severe malaria in infants...In the trial, infants (ages 6-12 weeks at first vaccination) receiving the RTS,S vaccine candidate experienced one-third fewer episodes of both clinical and severe malaria and experienced similar reactions to the injection when compared to those who received the control meningococcal C conjugate vaccine

The three clinical trials involve four of the top-ranked eye hospitals in the U.S., and two of the leading eye hospitals in the UK...Across the various clinical trial sites, with regular patient follow-up, no adverse safety issues relating to the transplanted cells have been observed...The clinical trial, called Transplantation In Myocardial Infarction Evaluation (TIME), was designed to see if heart function would improve by administering stem cells derived from the patient's own bone marrow either